Osteoarthritis
Conditions
Interventions
Placebo group:Intra-articular injection of 2.5ml 0.9% saline solution
Etanercept group:Intra-articular injection of 25mg/2.5ml Etanercept
Magnesium sulfate group:Intra-articular injection of 2.5ml 10% Magnesium sulfate
Sodium hyaluronate group:Intra-articular injection of 25mg/2.5ml sodium hyaluronate
Sponsors
Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
40 Years to 79 Years
Inclusion criteria
Inclusion criteria: (1) Aged 50–75 years; fulfilling the clinical and laboratory American College of Rheumatology (ACR) criteria for primary osteoarthritis; (2) With grade II to III (Kellgren and Lawrence system) radiographic stage osteoarthritis (unilateral or bilateral); (3) With clinical signs of synovitis (warmth, swelling or effusion),confirmed by MRI; (4) Persistent knee pain was defined as = 40 mm on a visual analogue pain scale (VAS) during the previous three months;global pain VAS in the contralateral knee < 30 mm; (5) Patients of reproductive potential agreed to take reliable means of contraception.
Exclusion criteria
Exclusion criteria: (1) Allergic to the agents; (2) Predominantly anterior knee pain; (3) Body mass index = 32Kg/M2 (4) Previous treatment with TNFi, or other biological agents; (5) Joint injection of sodium hyaluronate within 12 months; Joint injection of corticosteroids within 3 months; receiving NSAIDs during the previous 2 weeks; (6) A history of surgery within 10 years or trauma in the target knee; (7) Accompanied with other arthropathy in the target knee(); (8) Significant valgus/varus deformities; (9) Local or systematic infection; (10) Any acute or chronic infection or the history of active tuberculosis; (11) HBsAg positive, HCV-Ab positive; (12) Serious illness of the heart, lung, and other vital organs; any tumor history; (13) Liver function test equal to two times or greater than the upper normal limits; serum creatinine greater than the upper normal limit; (14) Pregnant women or breast-feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| KOOS pain score;VAS pain score; | — |
Secondary
| Measure | Time frame |
|---|---|
| KOOS function score;KOOS stiffness score;Patient global assessment;OMERACT-OARSI responders;12-Item Short-Form Health Survey (SF)-12 questionnaire;30-Second Chair Stand Test;40m Fast Paced Walk Test;MRI assessment of knee structural changes; | — |
Countries
China
Contacts
Public ContactGuanghua Lei
Xiangya Hospital, Central South University
Outcome results
None listed